Assessing Response to Treatment in Non-Hodgkin's Lymphoma Patients Using 64Cu-DOTA-Rituximab PET/CT

Part of paid clinical trials in Stanford, California.

Sponsor
Sanjiv Sam Gambhir
Study ID
NCT01598558
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

Rituximab is an antibody targeted against the CD20 antigen found primarily on B-cells. Therefore, an imaging agent targeting CD20 expression may provide a more accurate evaluation of extent of disease and response to therapy than the current standard of care, F-18 FDG PET/CT. The main purpose of the study is to investigate a new PET/CT imaging probe for detection and follow up of lymphoma. Following are the 3 aims of the study: a) Phase I testing in lymphoma patients of Cu-64 labelled Rituxan for defining normal tracer biodistribution, stability, pharmacokinetics and radiation dosimetry; b) comparison of Cu-64 Rituxan and F-18 FDG PET/CT in lymphoma patients; c) evaluation of changes in uptake of Cu-64 Rituxan in response to rituximab-based treatment in CD20-positive B-cell NHL

Key Dates

Start date
Jan 31, 2012
Status verified
Oct 2016
Primary completion
Dec 31, 2015
Completion
Dec 31, 2015

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 64Cu-DOTA
    Subjects will be injected with less than 14 mCi of 64Cu-DOTA-Rituximab. This is a slow infusion, done over 20 minutes.

Primary Outcome Measure

Change in pre and post treatment SUV max value on the 64CU-DOTA-Rituximab PET/CT and 18F FDG PET/CT [ Time Frame: baseline and 6 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford University Cancer InstituteStanfordCalifornia94305-

Find similar trials in Stanford, CA

By research site
Stanford University Cancer Institute· Stanford, CA

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